On 30 July 2024, the EU submitted to the WTO Circular G/TBT/N/EU/1079 proposing amendments to Annex XVII of REACH Regulation (EC) No 1907/2006 to add restrictions on N,N-dimethylacetamine (DMAC) and N-ethylpyrrolidone (NEP). Specific proposed revisions are as follows:
| Substance name | No. | Update details |
| N, N-dimethylacetamide (DMAC) | CAS No. 127-19- 5 EC No. 204- 826-4 | 1. 18 months after the entry into force of this regulation, it shall not be placed on the market as a single substance, as a component of other substances, or in a mixture at a concentration equal to or greater than 0.3% unless manufacturers, importers, and downstream users comply with relevant chemical safety regulations. Reports and safety data sheets contain no-effect levels (DNELs) for workers’ long-term inhalation exposure (13 mg/m³) and long-term dermal exposure (1.8 mg/kg body weight/day). 2. 18 months after the entry into force of this regulation, it shall not be manufactured or used as a single substance, a component of other substances, or in a mixture with a concentration equal to or greater than 0.3% unless the manufacturer and downstream users take appropriate risk management measures. And provide appropriate operating conditions to ensure worker exposure levels are below the DNELs specified in Article 1. 3. As an exception to Articles 1 and 2, with regard to the placing on the market or use as solvents for the production of man-made fibers, the relevant obligations apply 48 months after the entry into force of this Regulation. |
| 1-ethylpyrrolidin- 2-one (NEP) | CAS No. 2687- 91-4 EC No. 220- 250-6 | 1. 18 months after the entry into force of this regulation, it shall not be placed on the market as a single substance, as a component of other substances, or in a mixture at a concentration equal to or greater than 0.3% unless manufacturers, importers, and downstream users have notified themselves in the relevant chemical safety reports and safety reports. The information sheet contains no effect levels (DNELs) for workers’ long-term inhalation exposure (4.0 mg/m³) and long-term dermal exposure (2.4 mg/kg body weight/day). 2. 18 months after the entry into force of this regulation, it shall not be manufactured or used as a single substance, as a component of other substances, or in a mixture at a concentration equal to or greater than 0.3%, unless the manufacturer and downstream users take appropriate risk management measures and provide appropriate operating conditions to ensure that workers’ exposure levels are lower than those specified in Article 1. |
Resource：https://eping.wto.org/en/Search/Index? domainIds=1&countryIds=U918&viewData=G%2FTBT%2FN%2F EU%2F1079
